ID

45694

Beschreibung

Principal Investigator: Sekar Kathiresan, MD, Broad Institute, Cambridge, MA, USA MeSH: Myocardial Infarction,Inferior Wall Myocardial Infarction,Anterior Wall Myocardial Infarction https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001259 The VIRGO study is a four year research project funded by the NHLBI to study young women and men with heart attacks. A total of 2,000 women who are 18 - 55 years of age and a smaller comparison group of 1,000 similarly aged men will be enrolled in this multi-site observational study from approximately 120 different hospitals across the country. Young women have a much greater risk of dying after an acute myocardial infarction (AMI) than similarly aged men. Their mortality risk is markedly higher than that of young men, and limited data on young minority women suggest that they may have the highest risk of any young subgroup. Findings from the small number of published studies of young women with ischemic heart disease suggest that the biology, epidemiology, care, and outcomes of this group are distinct from those of men. To date, there have been no large studies of this population, even as the death toll is comparable to that from breast cancer in this country. This study will help researchers identify key factors that influence recovery from a heart attack and potentially improve the care and outcomes of young women and men with AMI. *Specific Aims:* To investigate the excess risk in young women with AMI and to identify key demographic, clinical, metabolic, psychosocial, health care delivery, and biological determinants of prognosis, we propose a national, prospective, observational study of 2,000 women who are 55 years or younger with AMI and a smaller comparison group of 1,000 men. Our prior work and preliminary studies indicate that the sex differences are most prominent in this age group and suggest that by 1 year after discharge, there are substantial sex differences in outcomes. We will also develop risk stratification tools that will help clinicians to identify young women with the highest and lowest risk. *Specific Aim 1:* Determine sex differences in outcomes following AMI. *Specific Aim 2:* Determine sex differences in the prevalence and prognostic importance of demographic, clinical, and psychosocial risk factors. * Specific Aim 3:*Determine sex differences in quality of care. *Specific Aim 4:* Determine sex differences in the prevalence and prognostic importance of selected biochemical biomarkers following AMI. *These samples have been whole genome sequenced as part of the NHGRI's Center for Common Disease Genetics at the Broad Institute.*

Link

dbGaP study = phs001259

Stichworte

Versionen (1)
  1. 09.05.23 09.05.23 - Simon Heim
Rechteinhaber

Sekar Kathiresan, MD, Broad Institute, Cambridge, MA, USA

Hochgeladen am

9. Mai 2023

DOI

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Lizenz

Creative Commons BY 4.0
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dbGaP phs001259 CCDG CVD: VIRGO - Variation in Recover-Role of Gender on Outcomes of Young Acute Myocardial Infarction (AMI) Patients

Englisch

Eligibility Criteria

5 Formulare  
Inclusion and exclusion criteria
Beschreibung

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
*INCLUSION CRITERIA* ------------------------------------------------------------------------------------------------------------ <ol type="1"> *
Beschreibung

INCLUSION CRITERIA

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
Age 18-55 * *
Beschreibung

Age 18-55

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001779
AMI Criteria: *Must meet both of the following criteria (2.1 AND 2.2)* * *2.1* Need at least one of the following elevated markers of myocardial necrosis:
Beschreibung

AMI Criteria: *Must meet both of the following criteria (2.1 AND 2.2)* * *2.1* Need at least one of the following elevated markers of myocardial necrosis:

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0155626
UMLS CUI [1,2]
C5444992
UMLS CUI [1,3]
C1442837
UMLS CUI [1,4]
C0162490
UMLS CUI [1,5]
C3163633
Troponin I or T level greater than the 99th percentile of the upper reference limit (URL)
Beschreibung

Troponin I or T level greater than the 99th percentile of the upper reference limit (URL)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920210
UMLS CUI [1,2]
C0585642
UMLS CUI [1,3]
C4699980
CK level > twice the upper reference limit (URL) with CK-MB activity level > 10% total
Beschreibung

CK level > twice the upper reference limit (URL) with CK-MB activity level > 10% total

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201973
UMLS CUI [1,2]
C1299400
UMLS CUI [1,3]
C0523584
UMLS CUI [1,4]
C0205217
CK value on the same draw or CK-MB mass greater than the 99th percentile of URL Do NOT include the following:
Beschreibung

CK value on the same draw or CK-MB mass greater than the 99th percentile of URL Do NOT include the following:

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201973
UMLS CUI [1,2]
C4699980
Post-PCI cardiac markers with no pre-existing ACS in the past 24h
Beschreibung

Post-PCI cardiac markers with no pre-existing ACS in the past 24h

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1271630
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1532338
UMLS CUI [1,4]
C1298908
UMLS CUI [1,5]
C0521987
UMLS CUI [1,6]
C0948089
Post-CABG cardiac markers with no pre-existing AMI *2.2* Supporting evidence of myocardial ischemia with at least one of the following:
Beschreibung

Post-CABG cardiac markers with no pre-existing AMI *2.2* Supporting evidence of myocardial ischemia with at least one of the following:

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0687676
UMLS CUI [1,2]
C0010055
UMLS CUI [1,3]
C1271630
UMLS CUI [1,4]
C1298908
UMLS CUI [1,5]
C0521987
UMLS CUI [1,6]
C0027051
UMLS CUI [2,1]
C3887511
UMLS CUI [2,2]
C0151744
Symptoms of ischemia
Beschreibung

Symptoms of ischemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0022116
ECG changes indicative of new ischemia (New ST-T changes; New or presumably new left bundle branch block (LBBB); Development of pathological Q waves)
Beschreibung

ECG changes indicative of new ischemia (New ST-T changes; New or presumably new left bundle branch block (LBBB); Development of pathological Q waves)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232326
UMLS CUI [1,2]
C0023211
UMLS CUI [1,3]
C0919919
Other evidence of pathological necrosis (imaging, pathology) *
Beschreibung

Other evidence of pathological necrosis (imaging, pathology) *

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332120
UMLS CUI [1,2]
C1521733
UMLS CUI [1,3]
C0027540
Presentation: *Must meet one of the following two criteria:* *
Beschreibung

Presentation: *Must meet one of the following two criteria:* *

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449450
UMLS CUI [1,2]
C5444992
Patient presented initially at this facility
Beschreibung

Patient presented initially at this facility

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449976
UMLS CUI [1,2]
C0018704
Patient was transferred here from another facility with 24h of original presentation
Beschreibung

Patient was transferred here from another facility with 24h of original presentation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030704
UMLS CUI [1,2]
C1554109
UMLS CUI [1,3]
C0018704
*EXCLUSION CRITERIA* ------------------------------------------------------------------------------------------------------------ **Patients are excluded if any of the following criterion was met:**
Beschreibung

EXCLUSION CRITERIA

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
Patient previously enrolled in VIRGO
Beschreibung

Patient previously enrolled in VIRGO

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1696073
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0947630
Non-English/non-Spanish speaking
Beschreibung

Non-English/non-Spanish speaking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1546417
UMLS CUI [2,1]
C1518422
UMLS CUI [2,2]
C0037750
Inability to provide informed consent
Beschreibung

Inability to provide informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C1999230
UMLS CUI [1,3]
C0021430
Inability to contact for follow-up (e.g. no access to phone, not planning on living in the country for next year)
Beschreibung

Inability to contact for follow-up (e.g. no access to phone, not planning on living in the country for next year)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C5549095
UMLS CUI [1,2]
C1522577
Acute MI due to chest trauma
Beschreibung

Acute MI due to chest trauma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0155626
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1337069
Currently a prisoner
Beschreibung

Currently a prisoner

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0205255
Other reason
Beschreibung

Other reason

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
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Ähnliche Modelle

Eligibility Criteria

5 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
INCLUSION CRITERIA
Item
*INCLUSION CRITERIA* ------------------------------------------------------------------------------------------------------------ <ol type="1"> *
boolean
C1512693 (UMLS CUI [1,1])
Age 18-55
Item
Age 18-55 * *
boolean
C0001779 (UMLS CUI [1,1])
AMI Criteria: *Must meet both of the following criteria (2.1 AND 2.2)* * *2.1* Need at least one of the following elevated markers of myocardial necrosis:
Item
AMI Criteria: *Must meet both of the following criteria (2.1 AND 2.2)* * *2.1* Need at least one of the following elevated markers of myocardial necrosis:
boolean
C0155626 (UMLS CUI [1,1])
C5444992 (UMLS CUI [1,2])
C1442837 (UMLS CUI [1,3])
C0162490 (UMLS CUI [1,4])
C3163633 (UMLS CUI [1,5])
Troponin I or T level greater than the 99th percentile of the upper reference limit (URL)
Item
Troponin I or T level greater than the 99th percentile of the upper reference limit (URL)
boolean
C0920210 (UMLS CUI [1,1])
C0585642 (UMLS CUI [1,2])
C4699980 (UMLS CUI [1,3])
CK level > twice the upper reference limit (URL) with CK-MB activity level > 10% total
Item
CK level > twice the upper reference limit (URL) with CK-MB activity level > 10% total
boolean
C0201973 (UMLS CUI [1,1])
C1299400 (UMLS CUI [1,2])
C0523584 (UMLS CUI [1,3])
C0205217 (UMLS CUI [1,4])
CK value on the same draw or CK-MB mass greater than the 99th percentile of URL Do NOT include the following:
Item
CK value on the same draw or CK-MB mass greater than the 99th percentile of URL Do NOT include the following:
boolean
C0201973 (UMLS CUI [1,1])
C4699980 (UMLS CUI [1,2])
Post-PCI cardiac markers with no pre-existing ACS in the past 24h
Item
Post-PCI cardiac markers with no pre-existing ACS in the past 24h
boolean
C1271630 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C1298908 (UMLS CUI [1,4])
C0521987 (UMLS CUI [1,5])
C0948089 (UMLS CUI [1,6])
Post-CABG cardiac markers with no pre-existing AMI *2.2* Supporting evidence of myocardial ischemia with at least one of the following:
Item
Post-CABG cardiac markers with no pre-existing AMI *2.2* Supporting evidence of myocardial ischemia with at least one of the following:
boolean
C0687676 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
C1271630 (UMLS CUI [1,3])
C1298908 (UMLS CUI [1,4])
C0521987 (UMLS CUI [1,5])
C0027051 (UMLS CUI [1,6])
C3887511 (UMLS CUI [2,1])
C0151744 (UMLS CUI [2,2])
Symptoms of ischemia
Item
Symptoms of ischemia
boolean
C1457887 (UMLS CUI [1,1])
C0022116 (UMLS CUI [1,2])
ECG changes indicative of new ischemia (New ST-T changes; New or presumably new left bundle branch block (LBBB); Development of pathological Q waves)
Item
ECG changes indicative of new ischemia (New ST-T changes; New or presumably new left bundle branch block (LBBB); Development of pathological Q waves)
boolean
C0232326 (UMLS CUI [1,1])
C0023211 (UMLS CUI [1,2])
C0919919 (UMLS CUI [1,3])
Other evidence of pathological necrosis (imaging, pathology) *
Item
Other evidence of pathological necrosis (imaging, pathology) *
boolean
C0332120 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
C0027540 (UMLS CUI [1,3])
Presentation: *Must meet one of the following two criteria:* *
Item
Presentation: *Must meet one of the following two criteria:* *
boolean
C0449450 (UMLS CUI [1,1])
C5444992 (UMLS CUI [1,2])
Patient presented initially at this facility
Item
Patient presented initially at this facility
boolean
C0449976 (UMLS CUI [1,1])
C0018704 (UMLS CUI [1,2])
Patient was transferred here from another facility with 24h of original presentation
Item
Patient was transferred here from another facility with 24h of original presentation
boolean
C0030704 (UMLS CUI [1,1])
C1554109 (UMLS CUI [1,2])
C0018704 (UMLS CUI [1,3])
EXCLUSION CRITERIA
Item
*EXCLUSION CRITERIA* ------------------------------------------------------------------------------------------------------------ **Patients are excluded if any of the following criterion was met:**
boolean
C0680251 (UMLS CUI [1,1])
Patient previously enrolled in VIRGO
Item
Patient previously enrolled in VIRGO
boolean
C1696073 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0947630 (UMLS CUI [1,3])
Non-English/non-Spanish speaking
Item
Non-English/non-Spanish speaking
boolean
C1546417 (UMLS CUI [1,1])
C1518422 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Inability to provide informed consent
Item
Inability to provide informed consent
boolean
C1299582 (UMLS CUI [1,1])
C1999230 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Inability to contact for follow-up (e.g. no access to phone, not planning on living in the country for next year)
Item
Inability to contact for follow-up (e.g. no access to phone, not planning on living in the country for next year)
boolean
C5549095 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
Acute MI due to chest trauma
Item
Acute MI due to chest trauma
boolean
C0155626 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1337069 (UMLS CUI [1,3])
Currently a prisoner
Item
Currently a prisoner
boolean
C0521116 (UMLS CUI [1,1])
C0205255 (UMLS CUI [1,2])
Other reason
Item
Other reason
boolean
C0205394 (UMLS CUI [1,1])
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